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510(k) Data Aggregation

    K Number
    K031319
    Device Name
    OSTEO-G BONE VOID FILLER SYSTEM
    Manufacturer
    ASPINE USA, INC.
    Date Cleared
    2003-07-17

    (83 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K010557,K963562,K963587,K010532,K991854,K003954,K013790
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASPINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.

    Device Description

    The Osteo-G Bone Void Filler System is an osteoconductive, bioabsorbable, calcium sulfate dihydrate implant for use as a bone graft substitute or bone void filler. The system consists of prefabricated calcium sulfate dihydrate pellets or a kit for fabricating calcium suffate dihydrate implants to custom shape and size or for in situ use. The device is radiopaque and is presterilized for single use.

    The Osteo-G Bone Void Filler System pellets are provided in three sizes, each with cylindrical shape, as follows:

    • a) 5 mm diameter, 5 mm high
    • b) 5 mm diameter, 3 mm high
    • c) 3 mm diameter, 3 mm high

    The Osteo-G Bone Void Filler System kit is provided in one size: a ten gram quantity of calcium sulfate hemihydrate powder component with a three milliliter mixing solution component. Once mixed, the powder and solution produce a moldable paste that can be custom shaped.

    AI/ML Overview

    This document describes the Osteo-G Bone Void Filler System, which is a medical device. Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI medical device.

    The document K031319 is a 510(k) premarket notification for a calcium sulfate bone void filler. This type of device is a physical biomaterial, not software or an AI system. The information provided relates to its classification, intended use, material composition, and equivalence to other legally marketed predicate devices, as required for a 510(k) submission.

    Therefore, I cannot fulfill your request for the acceptance criteria and study details as they pertain to an AI device. The input text does not contain any reference to AI, machine learning, or software performance evaluation.

    If you have a different document that pertains to an AI medical device, please provide that.

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